Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

Need to FAST Track Your Patent? The USPTO increases the Annual Limit to 20,000

What Makes a Good Cell and Gene Therapy Application?

A Tip for Improving Your “Improved” Jepson Claim: Include Written Description Support

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

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While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process. Researchers can use such AI platforms for identifying new biological targets associated with a particular disease, screening known compounds for new applications and designing new therapeutic compounds, among other applications.In this article, originally published in Law360, we explain the top 10 considerations for AI transactions involving use in drug discovery, which are:<ol><li>Consider the nature of the services being provided.</li><li>Be mindful of IP ownership.</li><li>Consider quality and privacy issues for training data.</li><li>Consider exclusivity.</li><li>Account for infringement risk.</li><li>Be reasonable with royalties.</li><li>Evaluate confidentiality and competitive use.</li><li>Plan for uncertainty.</li><li>Scrutinize contractual risk allocation.</li><li>Beware of an evolving regulatory landscape.</li></ol>For more detail on each of the considerations, read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltc9412c34b10121da/64499b26d57e320df0d8163a/230425-considerations-licensing-ai-drug-discovery.pdf">full article</a>.

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Stephanie assists companies with technology and life sciences transactions, representing both private and public companies, from emerging growth through the Fortune 50. In particular, Stephanie focuses on helping companies that leverage data through technology in structuring their business and commercial transactions.

Stephanie Sharron

Stephanie Sharron is partner in the Palo Alto office and a member of the firm’s Technology Transactions Group. Clients turn to Ms. Sharron for advice on how to leverage data through technology and the related issues that apply to their business models in light of the rapid changes in business, technology and law.

Stephanie Lynn Sharron

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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10 Considerations When Licensing AI for Drug Discovery

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While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process.

10 Considerations When Licensing AI for Drug Discovery

Licensing + Commercial

Regulatory

Intellectual Property

On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi, a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of equivalents (DOE) was brought up several times during oral arguments as an avenue to capture additional claim scope. Prior to the oral arguments, legal scholars had proposed, at least in the antibody context, to marry means-plus-function claim drafting to DOE as an approach to potentially salvage genus claims.[1] This article provides some insights on the use of DOE in life sciences cases.DOE is a long-standing doctrine judicially created to protect patent owners from alleged infringers who may circumvent the literal scope of a patent claim by making “unimportant and insubstantial” modifications to a patented invention. Over the decades since the doctrine was first established, courts have imposed major limitations on DOE to strike a balance between the inventor’s interest and public interest. One such limitation is prosecution history estoppel, which bars a patentee from recapturing through DOE subject matters surrendered during prosecution. However, in 2019, the Federal Circuit affirmed a finding of infringement under DOE in Eli Lilly & Co. v. Hospira, Inc.,[2] in spite of a narrowing amendment made during prosecution of Eli Lilly’s patent related to Alimta® for treatment of certain types of cancer with antifolates. The equivalents at issue were two pemetrexed salt forms, pemetrexed disodium and pemetrexed ditromethamine. An amendment from “an antifolate” to “pemetrexed disodium” was presented by Eli Lilly during prosecution in response to a prior art rejection. Finding that the rationale underlying the amendment bore no more than a tangential relation to the equivalent in question, the Federal Circuit affirmed that prosecution history estoppel did not bar Eli Lilly’s infringement claim under DOE.Following the guidance from the Federal Circuit, there has been an uptake on DOE related issues in the lower courts. For example, in 2020, the U.S. District Court for the District of Delaware addressed DOE in ViiV Healthcare Co. v. Gilead Sciences,[3] where ViiV alleged that Gilead’s product for HIV treatment, bictegravir, infringed claim 6 of U.S. Patent No. 8,129,385 (the “’385 patent”). Claim 6 of the ’385 patent is directed to dolutegravir, an active pharmaceutical ingredient used in HIV treatments. Based on the structural differences between the difluoro benzyl ring in ViiV’s dolutegravir and the trifluoro benzyl ring in Gilead’s bictegravir, Gilead moved for summary judgment, arguing the two-fluorines limitation in claim 6 specifically excludes compounds with three fluorines. The court denied Gilead’s motion for summary judgment of non-infringement, finding that ViiV was not barred from asserting an infringement claim under DOE. To end the legal battle, Gilead and ViiV reached a US$1.25 billion global settlement and licensing agreement in 2022. Given the recent attention on DOE, stakeholders should be aware that, even with its limitations, DOE can be a viable infringement theory in certain cases and should not be overlooked in strategic thinking on IP issues.[1] Lemley, Mark A. and Sherko, Jacob S., The Antibody Patent Paradox (February 2023), The Yale Law Journal.[2]Eli Lilly and Co. v. Hospira, Inc., No. 18-2126 (Fed. Cir. 2019).[3]ViiV Healthcare Co. v. Gilead Scis., Inc., No. 18-224 (D. Del).

Seagen Inc. v. Daiichi Sankyo Co. Ltd. et al. (AAA Arbitration, Eastern District of Texas, District of Delaware, and Patent Trial and Appeal Board)

Evolve BioSystems, Inc. v. Abbott Laboratories (Northern District of Illinois)

Driscoll’s, Inc. v. California Berry Cultivars, LLC (Eastern District of California)

Bayer CropScience LP v. Tenfold Tech., LLC (Eastern District of Texas)

The Regents of the University of California v. California Berry Cultivars, L.L.C. et al.  (California Superior Court and Northern District of California)

Arch Development Corp. v. Genentech, Inc. (Northern District of Illinois, Patent Trial and Appeal Board, and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. (Northern District of California and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. and ImmunoGen, Inc. (Patent Trial and Appeal Board and Federal Circuit)

Focal Therapeutics, Inc. v. Senorx, Inc. (Patent Trial and Appeal Board)

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Matthew protects his clients’ intellectual property and defends his clients wrongly accused of infringement. His hearing and trial experience is extensive. Whether exploring complex technical issues regarding a biologic drug, or digging into the finer points of patent law, he excels at keeping his opponents on their toes.

Matthew Chivvis

Matthew A. Chivvis

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Associate

Dr. Qiwen Zhong focuses on patent prosecution, freedom-to-operate analyses, and IP due diligence, with an emphasis on chemistry and pharmaceuticals.
Qiwen obtained her J.D. from UCLA School of Law whe

Qiwen Zhong Ph.D.

Qiwen Zhong

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Is DOE Now in Vogue?

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On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi, a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of equivalents (DOE) was brought up several times during oral arguments as an avenue to capture additional claim scope.

Is DOE Now in Vogue?

Litigation

Pharma

Biotech

United States

In a recent press release, the U.S. Patent and Trademark Office (USPTO) announced that, starting on April 18, 2023, the Office would begin issuing electronic patent grants (eGrants) to patent recipients. This process delivers the official copy of patent grants in an electronic format, instead of the previous paper version. The Office will still provide a bound paper version as a ceremonial copy throughout a limited transition period for free, and then for a nominal fee thereafter. In this article, MoFo’s Patent team explores the important implications of this change, particularly how it impacts the timing of filing continuing applications.Read the <a href="https://www.mofo.com/resources/insights/230412-uspto-to-launch-new-patent-issue-procedure" target="_blank">full client alert</a>.

USPTO to Launch New Patent Issue Procedure on April 18: What You Need to Know

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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USPTO to Launch New Patent Issue Procedure on April 18: What You Need to Know

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In a recent press release, the U.S. Patent and Trademark Office (USPTO) announced that, starting on April 18, 2023, the Office would begin issuing electronic patent grants (eGrants) to patent recipients. 

On April 3, 2023, the U.S. Plant Variety Protection Office (PVPO) held a preparatory session for the International Union for the Protection of New Varieties of Plants (UPOV) Technical Working Party for Vegetables (TWV) and Technical Working Party for Agricultural Crops (TWA) virtual meetings in May. This session was to provide an opportunity for feedback and comments on the UPOV Test Guidelines and the PVPO Exhibit C forms.In regard to the UPOV Test Guidelines, the PVPO will be submitting comments received on the PVPO Hemp (Cannabis) form to the UPOV Technical Working Party. As of April 3, 2023, there were no plans for the PVPO to submit comments on any of the other crops that will be discussed in the May meetings.In regard to the PVPO Exhibit C forms, the PVPO is currently in the process of aligning Exhibit C forms for all crops with the UPOV Test Guidelines. The Exhibit C forms are being updated on an as-requested basis, which means that only those forms that have been updated are currently available on the PVPO website. You can contact the Office (via <a href="mailto:AMS.PVPOForms@usda.gov">AMS.PVPOForms@usda.gov</a>) to request specific forms, ask about the status of specific forms, or ask other form-related questions. Over time, all of the forms will be updated.The PVPO stated that some older characteristics, which have been important for variety searches in the past, will be retained on the updated Exhibit C forms. In addition, the PVPO will retain quantitative traits in the updated Exhibit C forms.There is a new “area of adaptation” section on the updated Exhibit C forms, which will include options for both field-grown varieties and greenhouse-grown varieties. Over time, the PVPO will be updating its dashboard to display varieties by their area of adaptation, to facilitate variety searching. This dashboard will eventually replace the current certificate management system.If you have any comments on Exhibit C forms, they can be submitted to the Plant Variety Protection Office via email (<a href="mailto:pvpomail@usda.gov">pvpomail@usda.gov</a>), and the Examiner who handles the crops will review. MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team will continue to monitor developments related to the PVPO and will post future updates on our blog.

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Sr Patent Agent

Dr. Claire Bendix’s work focuses on patent preparation, patent prosecution, and matters pertaining to plant variety protection both in the United States and abroad. She also has experience in conducti

Claire L. Bendix Ph.D.

Claire Bendix

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Patent Agent

Dr. Deborah Pohlmann focuses on patent preparation and prosecution, specializing in biology.
Prior to joining the firm, Deborah earned her Ph.D. in biology from the Massachusetts Institute of Technolo

Deborah A. Pohlmann Ph.D.

Deborah Pohlmann

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael Ward

U.S. Plant Variety Protection Office Invited Comments on UPOV Test Guidelines and Is Aligning Exhibit C Forms with UPOV